This notification, S.O. 5980(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, designates specific devices as drugs under the Drugs and Cosmetics Act, 1940 (23 of 1940). Effective January 1, 2020, the following devices intended for use in human beings are specified as drugs: (i) Nebulizers; (ii) Blood Pressure Monitoring Devices; (iii) Digital Thermometers; and (iv) Glucometers. This decision follows consultation with the Drugs Technical Advisory Board, as per section 3(b)(iv) of the aforementioned Act. The notification is issued under F.No. X.11014/33/2018-DR and is signed by Dr. Mandeep K. Bhandari, Jt. Secy.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: A legislative act of India related to drugs and cosmetics.
Central Government: The executive authority of the Union of India.
Drugs Technical Advisory Board: An advisory board related to drugs and technical aspects.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy.
New Delhi: The capital of India.
Nebulizer: A medical device that administers medication in the form of a mist inhaled into the lungs.
Blood Pressure Monitoring Devices: Devices used to measure blood pressure.
Glucometer: A medical device for determining the approximate concentration of glucose in blood.
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[फा.स.ं एFस.11014/33/2018-डीआर]
डॉ. मनदीप के भंडारी, संयु/ सिचव
7047 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 3rd December, 2018
S.O. 5980(E).—In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940
(23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the
following devices intended for use in human beings for the purposes referred to in the said sub-clause as drugs with
effect from the 1st day of January, 2020, namely:-
(i) Nebulizer ;
(ii) Blood Pressure Monitoring Devices ;
(iii) Digital Thermometer ; and
(iv) Glucometer .
[F.No. X.11014/33/2018-DR]
DR. MANDEEP K BHANDARI, Jt. Secy.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.